Data collection and storage device

ABSTRACT

A data collection apparatus includes a network of sensing units for sensing a parameter. Each sensing unit of the network of sensing units includes a sensor, a first data storage device, a first receiving device, and a first transmitting device. The first data storage device is for storing data from the sensor. The first transmitting device is for transmitting data derived from the sensor. The apparatus also includes a single control unit. The single control unit includes a second receiving device, a second transmitting device, and a second data storage device. The second receiving device is for receiving data transmitted from the network of sensing units. The second data storage device is for storing the data received from the network of sensing units. The sensing units of the network of sensing units are each configured so a real time signal triggers a change in at least one from the group consisting of: (a) sensor data handling, (b) sensor data collection, (c) sensor data storage in the sensing unit, and (d) sensor data transmission to the single control unit.

This patent application claims priority of U.S. Provisional PatentApplication 60/169,364, filed Dec. 6, 1999. This patent application is adivisional of U.S. patent application Ser. No. 09/731,066, U.S. Pat. No.7,478,108 filed Dec. 6, 2000.

FIELD

This patent application generally relates to collecting and transmittingdata. More particularly, it relates to a device for sensing, storing andtransmitting data. Even more particularly, it relates to a device thatcan be attached to a structure or live subject for providing data aboutthe structure or live subject.

BACKGROUND

Art, photography, and scientific literature record long standinginterest in how humans or animals run, and details of what happens in acollision. Various systems for sensing, collecting, storing, andcommunicating data about moving systems and remote locations have beendescribed in the literature.

For example, in virtual reality systems the motion of the head and otherextremities is continuously monitored to provide feedback to thecomputer to enable updating of images, as mentioned in U.S. Pat. No.5,978,972 to Stewart et al (the “'972 patent”). The '972 patent alsonotes that systems have been developed for military applications tomonitor the orientation of a pilot's head to assist in targeting. Forthese applications the helmets must remain hardwired to supportinfrastructure.

One system for measuring and recording acceleration of a person's headin a sports helmet that does not require hard wiring to extensivesupport infrastructure is described in the '972 patent. The systemprovides accelerometers in the helmet for sensing impacts. Theaccelerometers communicate with memory for recording in real time datafrom the accelerometers. The memory can be in the helmet itself or datacan be transmitted from the helmet to a nearby receiver for storagethere, for example, on a computer hard drive. Either way, the datacollected from the accelerometers can be analyzed to detect the precisemotions of the head which precede a severe head injury.

A weather station described in U.S. Pat. No. 5,978,738 to Brown,describes a scheme for collecting weather data from a remote location.The station has two separable sections. A sensor section measures andrecords weather related information, such as local temperature,pressure, humidity, ambient light, and ambient static charge, forperiodic transmission to a receiver section. The receiver section canalso communicate with global weather reporting systems.

Other systems, such as the black box on an aircraft, store data fromsensors on a recording device having limited storage capacity. Storeddata is periodically overwritten and only the data for a specified timeperiod leading up to an event, such as a crash, is available after theevent. The black box must then be found so the data stored can beretrieved.

Other systems transmit external data in real time into a live subject,for example, to stimulate human organs, such as heart or ear, asdescribed in U.S. Pat. No. 4,532,930. Others transmit energy under theskin, for example, for recharging an implanted battery, as described inU.S. Pat. No. 6,067,474 to Schulman et al. These systems do notgenerally sense, collect, and store data though.

All the systems that sense and collect data, store the data, and thencommunicate the data have inefficiencies either in the data acquisitionor in the transmission of the data. Thus, a better system for acquiringand transmitting data is needed, and this solution is provided by thefollowing description.

SUMMARY

It is therefore an object of the present to provide a scheme forcollecting data that avoids collecting large amounts of unwanted dataand that collects desired data to provide more efficient datacollection;

It is a further object of the present patent application to provide adata collection device that can be triggered in real time;

It is a further object of the present patent application to provide adata collection device that can be triggered by an event sensed by thedevice;

It is a further object of the present patent application to provide adata collection device that can be remotely triggered by a user;

It is a feature of the present patent application that remote triggeringof the data collection device provides transmission of stored data froma time before an event occurred;

It is a further feature of the present patent application that the datacollection device has a sensing unit and a control unit, and the sensingunit has a receiver to receive a trigger signal from the control unit;and

It is an advantage of the present patent application that the datacollection device can provide real time data triggered by an event or bya user in response to a change in information about the structure orlive subject.

One aspect of the present patent application is a data collectionapparatus. The data collection apparatus includes a network of sensingunits for sensing a parameter. Each sensing unit of the network ofsensing units includes a sensor, a first data storage device, a firstreceiving device, and a first transmitting device. The first datastorage device is for storing data from the sensor. The firsttransmitting device is for transmitting data derived from the sensor.The apparatus also includes a single control unit. The single controlunit includes a second receiving device, a second transmitting device,and a second data storage device. The second receiving device is forreceiving data transmitted from the network of sensing units. The seconddata storage device is for storing the data received from the network ofsensing units. The sensing units of the network of sensing units areeach configured so a real time signal triggers a change in at least onefrom the group consisting of: (a) sensor data handling, (b) sensor datacollection, (c) sensor data storage in the sensing unit, and (d) sensordata transmission to the single control unit.

Another aspect of the present patent application is a data collectionapparatus. The data collection apparatus includes an embedded sensingunit for sensing a parameter comprising a sensor, a first data storagedevice, a first receiving device, and a transmitting device. The firstdata storage device is for storing data from the sensor. The firsttransmitting device is for transmitting data derived from the sensor.The apparatus also includes a control unit separate from the embeddedsensing unit. The control unit comprises a second receiving device, asecond transmitting device, and a second data storage device differentfrom the first data storage device. The second receiving device is forreceiving data transmitted from the embedded sensing unit. The seconddata storage device is for storing the data received from the embeddedsensing unit. The embedded sensing unit is configured so a real timesignal triggers a change in at least one from the group consisting of:(a) sensor data handling, (b) sensor data collection, (c) sensor datastorage in the sensing unit, and (d) sensor data transmission from thesensing unit.

Another aspect of the present patent application is a data collectionapparatus. The data collection apparatus includes a wearable sensingunit for sensing a parameter comprising a sensor, a first data storagedevice, a first receiving device, and a transmitting device. The firstdata storage device is for storing data from the sensor. The firsttransmitting device is for transmitting data derived from the sensor.The wearable sensing unit is wearable by a living subject. The apparatusalso includes a control unit separate from the embedded sensing unit.The control unit is separate from the wearable sensing unit. The controlunit comprising a second receiving device, a second transmitting device,and a second data storage device different from the first data storagedevice. The second receiving device is for receiving data transmittedfrom the wearable sensing unit. The second data storage device is forstoring the data received from the wearable sensing unit. The wearablesensing unit is configured so a real time signal triggers a change in atleast one from the group consisting of: (a) sensor data handling, (b)sensor data collection, (c) sensor data storage in the sensing unit, and(d) sensor data transmission from the sensing unit.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing will be apparent from the following detailed descriptionas illustrated in the accompanying drawings, for clarity not drawn toscale, in which:

FIG. 1 a is a block diagram of one embodiment of a sensing unit;

FIG. 1 b is a block diagram of one embodiment of a control unit;

FIG. 2 is a block diagram of an alternate embodiment of a sensing unit;

FIG. 3 is a block diagram of the powering scheme for the alternateembodiment in which power is transmitted to the sensing unit from thecontrol unit;

FIG. 4 is an exploded view of a replacement knee implant containing thealternate embodiment of the sensing unit hermetically sealed therein;and

FIG. 5 is a table illustrating the variety of sensors that can be usedwith the various embodiments.

DETAILED DESCRIPTION

The present applicants recognized that substantial efficiency incollecting, storing, and transmitting data could be provided. Theyrecognized that data from a moving or remote structure or live subjectmay be provided by mounting a sensing unit in or on the structure orsubject of interest. In one embodiment, the sensing unit has both asensor and a data storage device for storing data from the sensor. Theapplicants further recognized that providing a scheme in which the datastorage is controlled by a real time trigger solves a problem withpreviously existing systems.

In one embodiment, accelerometers, data storage, and a triggering schemeare mounted in a wearable device such as a sports helmet. The triggeringscheme can be data collected by the accelerometers that exceeds apredetermined threshold. The above-threshold data may be caused by anevent, such as a collision. If the high acceleration produced by acollision and measured by the accelerometers exceeds the threshold thisdata triggers a change in data handling. For example, data stored duringa specified time period before the triggering event may be retained anddata may continue to be collected and retained during and after theevent. Data collected from times before this specified time period maynot be retained. The system thus automatically distinguishes wanted andunwanted data. The triggering can also provide for transmission of thisdata to a control unit.

Triggering can also be provided by a change in other information aboutthe structure or live subject being monitored. In addition toinformation sensed by the sensors themselves, a change in informationotherwise observed about the structure or live subject by the analyst orby other sensors can provide the trigger. In addition to a change ininformation being an increase in activity or another parameter, a changein information can also be detection of no change in activity for anextended period of time, for example, indicating the death of the livesubject, or indicating potential injury from inactivity or repetitivestress.

The triggering scheme can be a signal transmitted to a receiver that ismounted in the helmet. The signal may be transmitted at any time by ananalyst at the control unit based on an observation of a change in someinformation about the structure or live subject. The signal may initiatedata storage or it may initiate data transmission. With eitherself-triggering or external triggering, collection and storage ofmassive amounts of unwanted data is avoided, while the specific datawanted is collected for transfer to the control unit.

Data collection system 20 includes sensor 22 connected to analog todigital (A/D) converter 24 connected to microprocessor 26. Sensor 22 canbe an accelerometer, displacement sensor, strain gauge, pressure gauge,thermometer, heart rate, EKG, or EEG monitor, blood test data monitor,force gauge, humidity monitor, growth rate or ripeness monitor, lightintensity gauge, radiation detector, chemical detector, corrosiondetector, or toxic gas monitor. A/D converter 24 converts analog sensedata to digital data that can be processed by microprocessor 26. A/Dconverter 24 can be of the successive approximation type, such as TexasInstruments TLC 2543; the Sigma Delta type, such as Analog DevicesAD7714; or the on board microcontroller type, such as MicrochipPIC16F8xx series or Motorola MC68HC11. A/D converter 24 can beintegrated on one chip with microprocessor 26.

Microprocessor 26 can be located on a micro-controller which has otherfunctions on board, such as A/D converter, memory, communications ports,and multiplexers. Microprocessor 26 can save a unique address for eachsensor unit in memory 28 so that microprocessor 26 it can query,activate, or send timing information to each sensor individually or toall sensors at once. For example the Microchip PIC16F8xx series is amicrocontroller that includes microprocessor, A/D converter,non-volatile flash memory, communications port, and SRAM. Microprocessor26 reads A/D converter, manages the programming of non-volatile memoryand sends sensor readings to the memory, communicates to the controlunit, provides for error checking on received and transmitted data,stores scaling coefficients to convert A/D bit values into physicalunits, manages threshold triggering or external triggering. The programto run the microprocessor is stored in non-volatile memory. This memorymay be on the microprocessor chip or on an external non-volatile memorychip. The operation of these programs can be changed by transmittingprogramming data to microprocessor 26 of sensor unit 20. Also connectedto microprocessor 26 are memory 28, RF receiver 30, RF transmitter 32,and power supply 34.

Memory 28 can be non-volatile memory, such as flash memory, disk drive,or tape drive. Receiver 30 can use radio communications of the amplitudeshift keyed, frequency shift keyed, or spread spectrum variety. Forexample, the RF Monolithics TR1000 transceiver provides RFcommunications in both directions in a very small package and consumesvery little power. Transmitter 32 is included in this transceiver or itcan be a separate component. Transmitter 32 can be a transformer coupledtransmitter for short range data transfer, a radio transmitter, such asa narrow band transmitter or a cellular phone for long rangetransmission, or a hard wired transmitter, such as an RS232 twisted pairwires or a wired phone line, or ethernet connection for internet access.Antenna 33 is connected to receiver 30 and transmitter 32 for the RFtransmitter type. It may be located outside housing 60 to allow RFcommunications unless housing 60 is made of a non-conductive materialsuch as polymer, ceramic, or glass. In this case antenna 33 is a traceon a printed circuit board within housing 60. If housing 60 is formed ofa conductive material, such as titanium, however, connection of antenna33 must be through an insulated feed through.

Power supply 34 is assembled from different parts. For implanted use,power supply 34 includes battery 36, power receiving coil 38 a,rectifier 40, over-voltage detect circuit 42 and carrier detect circuit44. Battery 36 may be either a non-rechargeable type or a rechargeabletype. Rechargeable batteries include nickel cadmium, nickel metalhydride, and lithium-ion. A fuel cell can also be used. Alternatively,power may be supplied by magnetic field coupling into a coil in thesensor unit from a coil in an adjacent unit. Carrier detect circuit 44provides a signal that is proportional to the magnitude of the voltagecoupled into power receiving coil 38 a.

Threshold levels are including in the programming stored in non-volatilememory, and levels can be changed by communications from a remotedevice. The mode of triggering can be changed from triggering based onthreshold to triggering from an external signal. These modes are alsostored in non-volatile memory.

In operation, sensors 22 provide sense data to A/D converter 24 and thento microprocessor 26 for storage in non-volatile memory 28, as shown inFIG. 1 a. Microprocessor 26 is programmed to recognize an event whendata from sensor 22 that exceeds a threshold value. It is programmed bycommands communicated from control unit 50. Programming can set thenumber of samples of sensed data collected per second, duration of datacollection, and the number of sensors sampled at one time or insequence. Data continues to be logged during the event and for a periodof time after the event. In addition, a programmable portion of recentdata stored in non-volatile memory 28 from before the event can beretained in memory so events leading up to the event can be analyzed aswell. Thus, the amount of data retained in non-volatile memory can beprogrammed in advance. In addition to triggering this change fromroutine data logging, the event may also trigger transmission of data tocontrol unit 50 which acts as a data reception system, as shown in FIG.1 b. Control unit 50 includes antenna 52, radio transceiver 54 andcomputer 56, such as a personal computer, hand held computer, or othermicroprocessor based device. Control unit 50 can also be connected tosense unit 20 through the internet Thus, only desired data from timearound the event is retained and transmitted to control unit 50. Theevent may be an acceleration higher than a preset value from acollision; displacement beyond a specified location providing excessivestrain; elevated pressure, temperature, or heart rate; an out of speclevel for EKG or EEG; blood test data that is out of normal range, etc.Alternatively, once the threshold level has been reached, data may betransmitted by transmitter 32 to control unit 50 in real time. Inanother alternative, a trigger signal can be transmitted from controlunit 50 to receiver 30 which directs collection, storage, ortransmission of data from sensor 24. For example, the received triggersignal can start data collection and storage or it can starttransmission of stored data, real time data, or a combination of storedand real time data.

Data collection system 20 can be attached to a natural structure, suchas an embankment, to soil to detect moisture, to an architecturalstructure, such as a building or bridge that is relatively difficult toaccess to detect inclination, subsidence, strain, or vibration, to avehicle, such as an aircraft, or to a live subject, such as a person,animal, or plant. It can be attached to a hoof, implanted, or wornexternally, such as in a helmet or belt. Data collection system 20 isvery small in size and does not interfere with normal movement. The livesubject can therefore be completely mobile, and is free to move as ifdata collection system 20 were not there at all.

Data collection system 20 is particularly suitable as an implantabledevice within the body of a human, animal, or plant for measuringinternal parameters, such as temperature, blood flow or blood pressurelevels, blood electrolyte and chemical levels, etc.

Power can be transmitted through the skin to implanted power supply 34.Power receiving coil 38 receives the AC transmission which is convertedto DC in rectifying circuit 40 to recharge implanted battery 36. Datacollection system 20 is enclosed in a hermetically sealed container 60which protects the electronics from the corrosive effects of bodyfluids. The present applicants found that a metal case fabricated oftitanium will permit sufficient radiated power to penetrate to fullycharge battery 36. The case can also be fabricated of a ceramicmaterial, such as Dow Coming Macor, which is machinable, and can be usedto produce hermetic packages. For metal housings, receiving coil 38 canbe connected to hermetically sealed electronics via a hermetic feedthrough and receiving coil 38 can be encapsulated in bio-compatableepoxy. This arrangement increases the efficiency of reception of powerfrom control unit 50. Sensor 22 may be any sensing device, as describedherein above, such as a sensor to detect implant micro-motion, internalpressure, torque, and loading.

Data collected by sensor 22 and stored in memory 28 is retained fortransmission to control unit 50 upon receipt of a trigger signal. Thetrigger signal may be transmitted from control unit 50 and received byreceiver 30. Alternatively it may be provided by the sensor data itself,as described herein above. A preset limit is programed in microprocessor26, and when data exceeds that limit, data is stored, retained, ortransmitted.

The system is particularly attractive for implantation since powerrequired for storing data in memory 28 is two orders of magnitude lessthan required for real time transmission. Similarly, if data is onlytransmitted when the data reaches a predetermined threshold or whentriggered by an external signal, substantially less power is used thanis required for periodic transmission. Battery 36 is a lithium batteryor another type of battery that provides long life and may be rechargedmany times. Recharging may be accomplished by placing the externalcontrol unit 50 within close proximity of sensor unit 20 so coils 38 aand 38 b are closely spaced to provide efficient magnetic coupling.Furthermore, these coils include ferrite cores to enhance coupling.Control unit 50 can program sensor unit 20 to reduce power consumptionby shutting power to unused sensors and data acquisition electronicswhile maintaining capability of monitoring the state of charge ofbattery 36. Once sensor unit 20 is fully charged it transmits its stateof charge to control unit 50 which displays that charging is complete onpersonal computer 56.

An alternative embodiment does not require an implanted battery butallows monitoring of implanted sensors, including measurements ofmotion, force, chemical composition, such as blood levels, andbioelectric parameters, such as EKG, EMG, and EEG. The development ofimproved implantable devices, such as orthopedic devices for replacementknees and hips, requires knowledge of their in vivo behavior. However,little is known about the actual loads borne by implanted devices invivo. Direct load measurement would provide extremely valuableinformation, for the improvement of device designs, and for the rapidrehabilitation of individuals in which devices have been implanted.Multichannel telemetry systems, combined with strain gauges, can providethis information.

The lack of in vivo measurements may be limiting our ability to designthe most effective orthopedic implants. Currently, the loads and momentsare theoretically determined from mathematical models that are oftenbased on idealizations of joint geometry, material properties, andmuscle physiology. The use of cadaver specimens may not reflect anaccurate model of the loads experienced in vivo.

In vivo data could be utilized in the design of new orthopedic implantsor other health care products. Rehabilitation could be tailored to aspecific patient, based on the knowledge provided by a smart implant.This would be more appropriate than prescribing the same rehabilitationprotocol to every patient. Biofeedback could be provided to the patientto protect them from loads that could be damaging. Conceptually, datacould be collected remotely without requiring an office visit by thepatient. This could lower the cost of administering health care, andcould allow for a patient to be more closely monitored.

If implantable telemetry systems are used in animal studies it wouldreduce the number of animals required to complete a chronic study.Currently, animals have to be sacrificed at predetermined time intervalsto do chronic studies. The use of an implantable telemetry system wouldallow data to be collected over the length of the study on a singleanimal.

The present applicantors developed an implantable telemetry system thatcan transmit data from multiple implanted sensors and is powered byinductively coupling energy from an external coil to an internal powerreception coil. The design of this system and test results of load datathat has been collected in vitro in a total knee implant will bedescribed below.

The present system combines advanced, micropower, analog/digitalintegrated circuits with new, miniature, low power microprocessors todevelop a versatile remotely powered, implantable sensor telemetrysystem.

In the present embodiment, sensor unit 20′ includes sensors 70 a, 70 ball connected to multiplexor 72 that is part of A/D chip 24 which can beAnalog Devices AD7714 that provides signal conditioning as well as A/Dconversion. The AD7714 features 3 true differential bridge inputs, 5pseudo differential inputs, a maximum resolution of 22 bits, andsoftware programmable gain of 1-128. Chip 24 also includes differentialamplifier 72, A/D converter 74, and digital filter 76. Data output fromA/D chip 24 is processed by microprocessor 26, which may be a PIC16Cmicrocontroller, and is transmitted by transmitter 32, which can be anRF surface wave acoustic oscillator, as shown in FIG. 2.

The microprocessor (PIC16C, MicroChip Technologies, Chandler Ariz.)allows the AD7714 to be reprogrammed through the serial port of apersonal computer (PC) before being implanted. Once programmed, theconfiguration is stored in nonvolatile, electrically erasable,programmable, read only memory (EEPROM), on the PIC16C. On power up, thePIC16C reads the EEPROM to configure the AD7714 for the appropriatechannel specific gain, filtering, and sample rate parameters. If areceiver is included, it can be reprogrammed after implanting.

The microprocessor also performs pulse code modulation (PCM) of asurface acoustic wave (SAW) radio frequency (RF) oscillator (RFMonolithics, Dallas, Tex.). PCM modulation is advantageous because it isrelatively less prone to interference compared to pulse width modulation(PWM) and pulse interval modulation (PIM). Furthermore, with PCM we areable to detect an error in RF transmission. This is accomplished bysending a checksum byte, which is the sum of the preceding data bytes.At the receiver, if the sum of the data bytes does not equal thechecksum byte, then an error flag is generated at the PC based receiver.

Control unit 50 includes PCM receiver 54 which contains a matched RF SAWoscillator, a level converter to generate RS-232 signals from the PCMdata stream, and PC based software to read, display and store thereceived data. It is noteworthy that the receiver is powered by a ninevolt battery within a handheld enclosure, allowing the receiver to bewearable by the subject with the implanted sense unit.

The requirements for powering an implantable system are extremelydemanding. The chemicals used in construction of the battery are oftentoxic and are not desirable in an implantable system, even if thebatteries can be hermetically sealed within the implant. The operatinglife of the telemetry system will always be limited by the operatinglife of the battery. If a battery were to be used in an implantableapplication, then the single largest component of the telemetry systemwould be the battery. This would limit the use of the telemetry systemto large implants.

To circumvent the use of batteries, remote powering is desirable.Magnetic near field coupling can be utilized to transfer power to theimplanted coil. An external coil is driven with AC current generating anAC magnetic field. When the receive coil is placed in this field an ACvoltage is generated on the receive coil. This voltage is then rectifiedand filtered to provide the DC power that is required to operate thetelemetry system. Remote powering through an orthopedic implant presentsa great challenge, as the efficiency of coupling is reduced greatly bythe presence of the metal implant between the transmitting and receivingcoil. Ideally, high frequencies (>125 kHz) would be utilized to increasethe coupling efficiency. However, the combination of shielding andlosses due to eddy currents presented by the implant preclude the use ofhigher frequencies. We found the most efficient frequency of operationwith the titanium implant was 1.5 kHz.

As shown in FIG. 3, function generator 80 (B&K precision) provides a 3 Vp-p AC signal at 1.6 kHz to 100 W audio power amplifier 82 (Samson,Inc.) which amplifies the signal and drives external (primary) coil 84 athat is constructed of 35 turns of 16 gauge magnet wire. The impedanceof external coil 84 a was 10 Ohms at the 1.6 kHz drive frequency. Thepower amplifier delivered 1.0 Amp of current at 35 Volts to externalcoil 84 a. External coil 84 a is seven inches in diameter, which allowsfor the coil to be placed around a patient's leg. Internal (secondary)coil 84 b consists of 2000 turns of magnet wire wound on a highpermeability ferrite core. Approximately 40 milliwatts of power could becoupled into the internal coil 84 b, which is more than adequate topower the telemetry system.

It is important that the addition of electronics to an implant not addadditional size or risk to the patient. To minimize these risks it is arequirement that sense unit 20′ and power reception coil 84 b behermetically sealed within the implant. An example of such anapplication is the use of such a telemetry system within a customdeveloped total knee implant, as shown in FIG. 4. This implant is thesame size and construction as implants placed into hundreds of thousandsof patients each year. A custom sensor unit was designed that wascapable of fitting in the stem extender of the tibial component of theknee implant. Four piezoresistive load cells 90 a, 90 b, 90 c, 90 d (NKBiotech, Minneapolis, Minn.) were located underneath tibial tray 92.Each was capable of measuring up to 200 pounds. Sensor unit 20′ wasmounted with remote powering coil 84 b, as shown in FIG. 4.

The telemetry system and the remote powering coil were placed in thestem extender of the implant, as shown in FIG. 4. Radio antenna 33 isthen sealed within hermetically sealed feedthrough 94 to allow for highfrequency transmission to be transmitted out of housing 60′.Polyethelene cap 96 is then added to protect antenna 33 from damageduring the implantation process. Load cells 90 a, 90 b, 90 c, 90 d intibial tray 92 are then attached to sense unit 20′ and tibial trayhousing 60′ is hermetically sealed to tibial tray 92 and hermeticfeedthrough 94 using electron beam welding.

To determine bit error rate, the applicants performed long term (2 days)monitoring of checksum errors with the transmitter at 15 feet from thereceiver with direct line of sight between the transmitter and receiverantennas. The bit error rate was measured at 10 ppm.

To test thermal stability, the applicants conducted temperature drifttests of one transmitter within our environmental chamber (Thermatron)from 15 to 50 deg. Celsius. Bridge completion (for the strain gaugeinputs) was provided outside the chamber using precision resistors.Temperature stability was determined to be 10 ppm/° C. for offsets, and100 ppm/° C. for gains.

The telemetry system was tested with a wide variety of different sensorsto verify compatibility. The fact that the gain and digital filteringare programmable allows for a number of different sensors to be usedwith the sensor unit system. FIG. 5 lists sensors that were tested orhave been verified to be compatible with the sensor unit system. Twodifferent versions of sensor units were designed, one that is compatiblewith DC sensors (resistance, of voltage output sensors) and one that iscompatible with sensors that require low power AC excitation (inductiveand capacitive sensors).

From FIG. 5 it is apparent that a wide variety of physical parametersmay be measured. For orthopedic implants, force transducers based onfoil or piezoresistive semiconductor gauges are commonly employed forload measurements. Inductive displacement transducers could be employedfor measurement of micro-motion of bone relative to an implant.

In a paper by D. D'Lima, J. Slamin, B. Morris, “An implantable telemetrysystem to measure intra-articular tibial forces”, Orthopedic ResearchSociety, Anaheim, Calif. 1999, the following results for the sensorunit, control unit, and power transfer scheme described herein abovedescribed here was described. The total knee implant application, testsdemonstrated that the implant could transmit through bone, cement andsoft tissue for 3 to 5 meters. Results comparing the magnitude ofapplied force to measured force show close agreement with a mean errorof 1.2% up to loads of 2000 N. When the location along the x axis wasconsidered, the mean error between the applied load location and themeasured load location was <1 mm for the 6 different locations tested.For location along the y axis, the mean error between applied andmeasured location was 0.4 mm for the 6 different locations tested. Whentibiofemoral axial compressive forces measured by the transducer werecompared with those calculated from knee moments in the 2-D model, themean error was <5% over 9 different combinations of flexion angles andloads (4).

Thus, a versatile remotely powered transmitter that can be applied to anumber of different orthopedic applications has been developed. It wasshown that it is feasible to inductively couple enough power through atitanium orthopedic implant to power the sensors and electronics. Thesystem was verified to work with a number of sensors and testing of thesystem in vitro in a total knee implant has been successful. Direct invivo load measurement will provide extremely valuable information forimprovement of implant designs and may aid in the rapid rehabilitationof individuals in which devices have been implanted.

Sensor units mounted in wearable braces or on structures, such asbridges, buildings, or aircraft frames, can be used as well as withimplants mounted within live subjects. All such sensor units can includedatalogging, wireless data communications, and various sensors.

Datalogging allows for very fast data collection, but previous designsrequire a direct (hard wired) connection to a host computer in order toallow the data to be downloaded to the host computer for short termviewing and for long term analysis. The present applicants developed abi-directional RF communications link to trigger a sample to be logged,as well as to request data to be transmitted to the host computer.

The present applicants designed and built a complete system for fastdata collection and wireless data communications from an implanted orworn sensor array to a remote data acquisition system (DAS) hosted by apersonal computer.

A small digital data transceiver, datalogger, analog signal conditioner,and triaxial accelerometer package (approximately the size of twodominoes) is affixed to various limb segments for linear and angularposition/acceleration measurement. They may also be mounted tostructures for measuring displacements and vibrations.

The subject wearing the brace with the sense unit is allowed to performthe activity to be monitored (skiing, boxing, football, tennis, etc.).

Control unit antenna 52 is placed within 95 feet of the subject, andcontrol unit 50 can trigger microprocessor 26 to begin logging data tonon-volatile memory 28 by sending a “request to begin sampling” byte tosense unit 20.

The duration of logging, or data sample duration, is factory programmedfrom 5 to 20 seconds typical. For three channels of 16 bit data, 5seconds uses approx. 0.5 megabits of data.

The subject or structure under test is brought within range (10-15 feet)of the host transceiver, and the host sends a “request to download data”byte from the remote (foot mounted) transceiver. At 9600 bits per second(baud) rate, data download is complete in approximately one minute.

To collect more data on additional runs with the same subject, thecontrol unit sends a “request to begin sampling” byte again. Dependingon how much memory is available, the sense unit may add to or overwritedata saved in remote datalogger's memory 28 with data from the new run.

Control unit 50 can also transmit timing and address information toactivate all sensor units or to activate specific sensor units based onthe address of the individual sensor unit. While the processor may keeptrack of time, it is advantageous for control unit 50 to periodicallytransmit a time synching signal to one or more sensor units that resetsa clock on microprocessor 26 in sensor unit 20 to a known timereference. This is especially advantageous when trying to synchronize toanother sensor device, such as a video camera, which could requiremillisecond level time resolution and could be synchronized by thetiming signal from control unit 50. Control unit 50 uses softwarecapable of saving and displaying data downloaded from sense unit 20.

Most efficient use of non-volatile memory 28 can be tailored in softwarefor specific applications. For example, slowly changing data (such astemperature) can be sampled infrequently. Conversely, very fast eventscould be sampled when triggered by an event (or by the externaltransceiver) for short time periods. Data could be downloaded on requestfrom the external transceiver 54, as required by the application. Toprevent accidental loss, microprocessor 26 can ensure that no data inmemory 28 is overwritten unless data is successfully downloaded tocontrol unit 50 first.

The present patent application is also applicable to sensing chemicalreactions such as curing of composite materials. One or more sensorunits 20 can be embedded within a composite structure, remotely powered,and interrogated by personal computer 56 through a non-contactinginductive link, such as coils 84 a, 84 b.

The present applicants enhanced sensor unit function by developingspecialized sensor units for use with accelerometers, inclinometers,strain gauge rosettes, inductive transducers, and capacitive sensors.Sensor unit packaging has been subjected to environmental testing toinsure robustness, and suitability for use in the target compositematerial.

A system was developed that was shown to transfer 15 mA through radioabsorptive graphite composite 10 mm thick, using 25 watts of excitationpower. This excitation signal also carried interrogation command dataencoded by shifting the frequency of the power carrier.

It has been noted that the viability of such a system for curetemperature monitoring in composite panel fabrication processes would bedramatically improved if the gap between the excitation coil and theembedded sensor network could be increased to 150 mm.

It is technically difficult to achieve full power operation(continuously sampling, powering, and transmitting data at the maximumdata rate) of the embedded sensor unit with 150 mm gap. Assuming aconstant power applied to the excitation coil, the power induced in thereceiving coil drops inversely proportional to the cube of the distancefrom the excitation coil. This means if the distance is doubled to 20mm, the available power is reduced by a factor of 8. As the distance isincreased ten times (to 100 mm) the available power is now reduced by afactor of 1000. The 150 mm represents a 15 times increase in distanceover the originally specified 10 mm gap between excitation and receivecoils. This theoretically requires an increase in excitation power or areduction in embedded system power requirements, this reduction in powerrequirement can be achieved by data logging rather than by continuous RFdata transmission. The data is then retrieved when it is possible toeither increase power or reduce the distance between excitation andreceiving coils 84 a, 84 b. The present applicants have found that thecurrent draw of the embedded sensor unit will be reduced to less than100 uA by datalogging.

As previously discussed, a barrier to powering these devices from alonger range is the requisite supply current of the embedded system.Currently, the largest power requirement of the embedded system is thedata transmission system that is required to receive data from the hostand transmit data from the structure. If the power requirements werereduced, than the distance between the powering coil and the embeddedreceiving coil could be increased. It is acceptable to collect dataduring the temperature curing process and save the data internally fortransmission at a later time after the cure is complete. After the cureis complete, it is also acceptable to allow closer coupling between theexternal and embedded coils, which allows for data to be transmitted outof the composite.

The sensor units power down the transmitters and receivers during datacollection, saving significant power supply current. In addition, if thebandwidth required of the sensor measurements is low, the power could bereduced even more through the use of sensor power multiplexing andreduction in microprocessor clock frequency. Sensor multiplexing meansthat power is applied to the sensors only when being sampled, whichreduces the average power over time required by the sensors. Reducingthe frequency of the processor clock will also lower the power requiredby the system due to a reduction in CMOS switching losses. For example,by reducing the clock frequency by a factor of four and utilizingdatalogging as opposed to constantly transmitting data, the power can bereduced by an order of magnitude. In the case of temperature sensing, wewould be able to reduce the power by two orders of magnitude, due to lowcurrent consumption and low data bandwidth required by these sensors.

The downloading of the data is managed by modulation of the level of thepower to the embedded system. When the coupled power is great enough,then this will indicate to the embedded node to place the sensor unit indownload data mode to download the logged data. Along with the loggeddata, a confirmation byte that a complete data set has been stored istransmitted to the control unit. As long as the power level ismaintained above a certain threshold, the embedded node willcontinuously retransmit the contents of the logged data memory. Thiswill ensure that data will be received in its entirety. When the powercoupled is low, the system reverts to low power data collection mode. Inthis manner, the external system has full control of the mode of theembedded sensor unit by controlling the transmitted power level.

While the disclosed methods and systems have been shown and described inconnection with illustrated embodiments, various changes may be madetherein without departing from the spirit and scope of the invention asdefined in the appended claims.

1. A data collection apparatus, comprising: a network of sensing unitsfor sensing a parameter, wherein each sensing unit of said network ofsensing units includes a sensor, a first data storage device, a firstreceiving device, and a first transmitting device, said first datastorage device for storing data derived from said sensor, said firsttransmitting device for transmitting data derived from said sensor; asingle control unit, said single control unit comprising a secondreceiving device, a second transmitting device, and a second datastorage device, said second receiving device to receive data transmittedfrom said network of sensing units, said second data storage device forstoring said data received from said network of sensing units whereinsensing units of said network of sensing units are each configured so areal time signal triggers a change in at least one from the groupconsisting of: (a) sensor data handling, (b) sensor data collection, (c)sensor data storage in said sensing unit, and (d) sensor datatransmission to said single control unit.
 2. The apparatus as recited inclaim 1, wherein said sensor comprises at least one from the groupconsisting of an accelerometer, a displacement sensor, a strain gauge, apressure gauge, a thermometer, a flow monitor, a heart monitor, anelectrocardiogram (EKG), an electromyogram (EMG), anelectroencephalogram (EEG), a blood monitor, a force gauge, a humiditymonitor, a growth rate monitor, a ripeness monitor, a light intensitygauge, a radiation detector, a chemical detector, a corrosion detector,and a toxic monitor.
 3. The apparatus as recited in claim 2, whereinsaid sensor comprises an array of accelerometers.
 4. The apparatus asrecited in claim 2, wherein said sensor comprises a linearaccelerometer.
 5. The apparatus as recited in claim 2, wherein saidsensor comprises a resistive accelerometer.
 6. The apparatus as recitedin claim 2, wherein said sensor comprises an angular accelerometer. 7.The apparatus as recited in claim 2, wherein said sensor comprises apiezoelectric accelerometer.
 8. The apparatus as recited in claim 1,wherein said sensor detects vibration.
 9. The apparatus as recited inclaim 1, wherein a sensing unit of said network of sensing units isattached to at least one from the group consisting of an architecturalstructure and a vehicle.
 10. The apparatus as recited in claim 1,wherein a sensing unit of said network of sensing units is worn.
 11. Theapparatus as recited in claim 1, wherein a sensing unit of said networkof sensing units is embedded.
 12. The apparatus as recited in claim 1,further comprising a hermetically sealed housing, wherein a sensing unitof said network of sensing units is located in said hermetically sealedhousing.
 13. The apparatus as recited in claim 12 wherein saidhermetically sealed housing comprises at least one from the groupconsisting of titanium and ceramic.
 14. The apparatus as recited inclaim 12, wherein said sensing unit further comprises an antenna,wherein said antenna extends outside said hermetically sealed housingand is connected within said hermetically sealed housing through apenetration in said hermetically sealed housing.
 15. The apparatus asrecited in claim 1, wherein each sensing unit of said network of sensingunits further comprises a microprocessor.
 16. The apparatus as recitedin claim 15, wherein said microprocessor is connected to said firststorage device, said first transmitting device, and said first receivingdevice.
 17. The apparatus as recited in claim 15, wherein saidmicroprocessor comprises a triggering device for triggering said change.18. The apparatus as recited in claim 15, wherein said microprocessorcomprises a triggering device that initiates transmission of data fromsaid sensing unit to said control unit, wherein said triggering deviceis controlled by a real time change in said data.
 19. The apparatus asrecited in claim 1, wherein each sensing unit of said network of sensingunits further comprises a power supply.
 20. The apparatus as recited inclaim 19, wherein said power supply comprises a rechargeable battery.21. The apparatus as recited in claim 20, further comprising a circuitfor recharging said battery by inductive coupling.
 22. The apparatus asrecited in claim 21, further comprising a hermetically sealed housing,wherein said sensor and said circuit for recharging are in saidhermetically sealed housing and said coupling is through saidhermetically sealed housing.
 23. The apparatus as recited in claim 21,wherein said circuit for recharging is in said hermetically sealedhousing and an antenna for said coupling is located outside saidhermetically sealed housing.
 24. The apparatus as recited in claim 1,wherein said first receiving device comprises an RF receiver forreceiving said real time signal.
 25. The apparatus as recited in claim1, wherein said first transmitting device includes an RF transmitter.26. The apparatus as recited in claim 1, wherein each sensing unit ofsaid network of sensing units unit includes a clock, wherein saidcontrol unit includes a time reference, and wherein said secondtransmitting device is configured to send a timing signal to eachsensing unit of said network of sensing units for synchronizing saidclocks to said time reference.
 27. The apparatus as recited in claim 26,wherein said first storage device is connected to receive and recordsaid timing signal.
 28. The apparatus as recited in claim 26, whereinsaid timing signal synchronizes clocks on said sensing unit and onanother apparatus.
 29. The apparatus as recited in claim 1, wherein saidfirst data storage device continually records.
 30. The apparatus asrecited in claim 1, wherein said first data storage device is controlledby data received by said sensor.
 31. The apparatus as recited in claim30, wherein when said data derived from said sensor reaches a threshold,data in said first storage device is retained.
 32. The apparatus asrecited in claim 31, wherein said retained data includes data receivedafter said data derived from said sensor reaches said threshold.
 33. Theapparatus as recited in claim 1, wherein said sensing unit furtherincludes a feedback device for adjusting said parameter based on saiddata.
 34. The apparatus as recited in claim 33, wherein when said dataderived from said sensor reaches a threshold, data in said first storagedevice is retained.
 35. The apparatus as recited in claim 34, whereinsaid retained data includes data received after said data derived fromsaid sensor reaches said threshold.
 36. The apparatus as recited inclaim 1, wherein a sensing unit of said network of sensing units furthercomprises a feedback device for adjusting said parameter based on saiddata.
 37. The apparatus as recited in claim 36, further comprising asensor for detecting excessive vibration, wherein said feedback deviceis an active damping element to reduce vibration in response toexcessive vibration.
 38. The apparatus as recited in claim 1, whereinsaid second data storage device comprises a computer.
 39. The apparatusas recited in claim 1, wherein said control unit further comprises adevice to signal a user that data exceeding a preset threshold has beenreached.
 40. The apparatus as recited in claim 1, wherein said secondtransmitting device is connected to transmit address information to saidnetwork of sensing units to activate at least one from the groupconsisting of all of said sensing units, specific ones of said sensingunits, and an individual sensing unit of said network of sensing units.41. The apparatus as recited in claim 1, further comprising a hostcomputer, wherein said control unit is connected to said host computer.42. The apparatus as recited in claim 41, wherein said host computer isconfigured to accept user input, wherein a user operating on said hostcomputer sends a signal for triggering data collection.
 43. Theapparatus as recited in claim 42, further comprising a triggeringdevice.
 44. The apparatus as recited in claim 1, wherein each saidsensing unit of said network of sensing units is configured so dataderived from said sensor triggers transmission from said sensing unit tosaid control unit.
 45. The apparatus as recited in claim 44, whereineach said sensing unit is configured to trigger transmission from saidsensing unit to said control unit once sensor data exceeds a thresholdvalue.
 46. A data collection apparatus, comprising: an embedded sensingunit for sensing a parameter comprising a sensor, a first data storagedevice, a first receiving device, and a transmitting device, said firstdata storage device for storing data derived from said sensor, saidfirst transmitting device for transmitting data derived from saidsensor, wherein said embedded sensing unit is embedded in one from thegroup consisting of a structure and a living subject; a control unitseparate from said embedded sensing unit, said control unit comprising asecond receiving device, a second transmitting device, and a second datastorage device different from said first data storage device, saidsecond receiving device to receive data transmitted from said embeddedsensing unit, said second data storage device for storing said datareceived from said embedded sensing unit wherein said embedded sensingunit is configured so a real time signal triggers a change in at leastone from the group consisting of: (a) sensor data handling, (b) sensordata collection, (c) sensor data storage in said sensing unit, and (d)sensor data transmission from said sensing unit.
 47. A data collectionapparatus, comprising: a wearable sensing unit for sensing a parametercomprising a sensor, a first data storage device, a first receivingdevice, and a transmitting device, said first data storage device forstoring data derived from said sensor, said first transmitting devicefor transmitting data derived from said sensor, wherein said wearablesensing unit is wearable by a living subject; a control unit separatefrom said wearable sensing unit, said control unit comprising a secondreceiving device, a second transmitting device, and a second datastorage device different from said first data storage device, saidsecond receiving device to receive data transmitted from said wearablesensing unit, said second data storage device for storing said datareceived from said wearable sensing unit wherein said wearable sensingunit is configured so a real time signal triggers a change in at leastone from the group consisting of: (a) sensor data handling, (b) sensordata collection, (c) sensor data storage in said sensing unit, and (d)sensor data transmission from said sensing unit.